DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This office action is in response to the amendment filed February 6th, 2026.
The applicant has cancelled claims 2-4, 6, and 7. Claim 5 has been previously withdrawn.
Claims 1 and 8-16 are pending and were examined on the merits.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a
prior Office action.
Any objections or rejections not reiterated below are hereby withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 17th, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement filed July 3rd, 2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because of possible missing or unidentified documents, as explained below. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a). The foreign reference place in the file wrapper does not recite the document number TW 202137991 A or by the applicant Newman et al. in the heading, so it is not clear whether this foreign patent document is TW 202137991 A submitted by the applicant Newman et al. It is not clear whether non-patent literature document 1 has a corresponding original, untranslated copy in the file wrapper of the instant application.
The foreign patent document TW 202137991 A was uploaded and cited on the PTO-892 form.
Drawings
The drawings were received on April 18th, 2023. These drawings are acceptable.
Withdrawal of Objections and Rejections
Applicant’s arguments, filed February 6th, 2026, with respect to the rejection of claims 1 under 35 U.S.C. 112(a) have been fully considered and are persuasive. The applicant has amended independent claim 1 to recite “SARS-CoV-2 infection”, and removed the broader limitation of “CoV infection” which lacked support in the instant specification. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of the reasons recited below in the new rejection of claims 1 and 8-16 under 35 U.S.C..
The rejection of claims 2-4 and 7 under 35 U.S.C. 112(a) has been withdrawn, these claims having been cancelled by the applicant.
Applicant’s arguments, filed February 6th, 2026, with respect to the rejection of claims 1 and 8-16 have been fully considered and are persuasive. The rejection of claims 1 and 8-16 under 35 U.S.C. 103 has been withdrawn. The applicant has amended independent claim 1 to recite preventing SARS-CoV-2 infection, removing the limitations of inhibiting, reducing, and/or eliminating SARS-CoV-2 infection. Preventing SARS-CoV-2 infection is not enabled by the prior art (see rejection under 35 U.S.C. 112(a)), and not taught by prior art recited in the previous office action either individually or in combination. Therefore, the subject matter of independent claim 1 and dependent claims 8-16 is nonobvious over the prior art.
The rejection of claims 2-4 and 7 under 35 U.S.C. 103 has been withdrawn, these claims having been cancelled by the applicant.
The rejection of claims 2-4 and 7 under nonstatutory double patenting has been withdrawn, these claims having been cancelled by the applicant.
Pending Objections and Rejections
Specification
The use of the terms Invitrogen, Gibco, Biological industries (registered as BI Biological Industries), HyClone, Polysciences, Sigma (registered as Sigma-Aldrich, and Millipore Sigma), GeneTex, Zeiss, Dynabeads, ThermoFisher (registered as Thermo Fisher), and GraphPad Prism, each of which is a trade name or a mark used in commerce, has been noted in this application. Each term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 8-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12122809 (reference patent document). Although the claims at issue are not identical, they are not patentably distinct from each other because of overlapping subject matter, as recited in the prior office action, and clarified blow in view of the applicant's amendment. The analogous ground of rejection in the previous office action contained a typographical error implying that U.S. Patent No. 12122809 contains claims 1-20, when it only has claims 1-15. This typographical error is corrected above.
Applicant's arguments filed February 6th, 2026 have been fully considered but they are not persuasive. Although the reference patent document does not explicitly recite preventing SARS-CoV-2 infection, the applicant has defined the term "preventing" to reduce the frequency or severity of symptoms of a medical condition in a subject, relative to a subject which does not receive the agent (instant specification, paragraph [0030]). This definition of the term preventing overlaps with the term "treating" as broadly understood in the art, or inhibiting symptoms induced by an infection. Claims 1-20 of the reference patent documents are directed toward "A method for alleviating and/or treating a SARS-CoV-2 disease in a subject in need thereof" (reference claims 1-12) and "A method for inhibiting SARS-CoV-2-induced inflammation in a subject in need thereof" (reference claims 13-15). In view of the overlap between preventing SARS-CoV-2 infection as instantly claimed and specified, and the subject matter of the reference claims recited above, the double-patenting rejection of instant claims 1 and 8-16 over claims 1-15 of U.S. Patent No. 12122809 is maintained.
Claims 1 and 8-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 8 of U.S. Patent No. 12018055 (reference patent document). Although the claims at issue are not identical, they are not patentably distinct from each other because of the overlapping subject matter recited below.
Reference claims 1 and 8-16 and instant claims 1 and 2 (in view of (instant specification, paragraph [0030]) both teach a method for preventing or treating a viral infection, comprising administering to a subject in need thereof an effective amount of an immunomodulatory protein of Ganoderma that reasonably encompasses GMI and comprises the amino acid sequence of: MSDTALIFTLAWNVKQLAFDYTPNWGRGRPSSFIDTVTFPTVLTDKAYTYRVVVSGKDLGVRPSYAVESDGSQKINFLEYNSGYGIADTNTIQVYVID PDTGNNFIVAQWN. The preventing or treating of a viral infection by administering an immunomodulatory protein of Ganoderma implies that administering of the immunomodulatory protein of Ganoderma decreases an infectivity of a virus that causes the viral infection (reference claim 8).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 8-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of inhibiting or reducing SARS-CoV-2 infection in a subject in need thereof, comprising administering an effective amount of Ganoderma immunomodulatory protein comprising SEQ ID NO: 3, does not reasonably provide enablement for a method of preventing SARS-CoV-2 infection in a subject in need thereof, comprising administering an effective amount of Ganoderma immunomodulatory protein comprising SEQ ID NO: 3 The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The applicant recites the following definition of the term “preventing”: “The term ‘preventing’ or ‘prevention’ is recognized in the art, and when used in relation to a condition, it includes administering an agent to reduce the frequency or severity of or to delay the onset of symptoms of a medical condition in a subject, relative to a subject which does not receive the agent” (instant specification paragraph [0030]). However, this definition is inclusive. So, within the context of claim 1, the term “preventing” could be understood as implying preventing SARS-CoV-2 infection in an absolute sense, not merely reducing the frequency or severity of or to delay the onset of symptoms.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method for preventing SARS-CoV-2 infection in a subject in need thereof. Thus, the claims taken together with the specification imply that the method recited in the claims prevents SARS-CoV-2 infections from developing in subject organisms.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
Fung et al. (Hong Kong Med J 2011, 17 (Suppl 2), S41-3) recites Ganoderma lucidum inhibiting SARS-CoV RNA dependent RNA polymerase in a dose-dependent manner (Results, Anti-viral assays), but does not recite a protein responsible for this inhibition, and does not recite the prevention of a SARS-CoV infection.
Ansor et al. (BMC Complement Altern Med 2013, 12, 256) explored the anti-ACE (anti-angiotensin converting enzyme) potential of protein fractions from the mycelia of Ganoderma lucidum. The authors report “Preliminary result demonstrated that the mycelia crude water extract inhibited ACE at IC50 value of 1.134 ± 0.036 mg/mL. Following protein fractionation and HPLC purification, the presence of highly potential anti-ACE proteins with the IC50 values less than 200 μg/mL was detected” (Abstract, Results). This reference does not recite an ACE inhibitory activity of a Ganoderma immunomodulatory protein having the sequence referenced in instant claim 1 (SEQ ID NO: 3, instant specification paragraph [0011]). This reference does not recite the prevention of a SARS-CoV infection.
Guo (CN-113208020-A) recites the following regarding Ganoderma proteins and preventing coronavirus, as class of viruses to which SARS-CoV-2 belongs: "The "Molecules (Molecules") of the International Academic Digest of the Year 2020 published the "natural active compound of a fungus as a potential candidate for the coronavirus as a protease inhibitor and an immunomodulator. The article points out: The fungus, especially lucid ganoderma, includes: ganoderma lucidum, ganoderma lucidum, active compound (triterpenes, polysaccharide and small molecular protein) of ganoderma lucidum, has the function of inhibiting HIV protease and adjusting immunity, providing a potential candidate medicine for preventing and treating coronavirus, in the future can be used for treating coronavirus, especially for preventing novel coronavirus infection" (Guo, Beneficial effects, subheading (3)). Guo suggests Ganoderma as a potential candidate medicine for preventing and treating coronavirus based on inhibiting HIV protease and adjusting immunity. This argument implies a speculation that Ganoderma could be used for preventing and treating coronavirus infection, but Guo does not supply direct evidence for this thesis form a coronavirus infection model.
Since the prevention or treatment of a coronavirus infection by administering a Ganoderma immunomodulatory protein remains largely unsolved, means for preventing a SARS-CoV-2 infection in a subject in need thereof by administering an effective amount of Ganoderma immunomodulatory protein is highly unpredictable.
(5) The relative skill of those in the art:
The relative skill of those in the art is high. Fung et al. recites Ganoderma lucidum inhibiting SARS-CoV RNA dependent RNA polymerase. Ansor et al. discovered evidence of proteins from Ganoderma lucidum having anti-ACE activity. Guo recites Ganoderma lucidum inhibiting HIV protease and adjusting immunity to support the thesis that Ganoderma is a potential candidate for preventing and treating coronavirus.
Accordingly, one would have turned to the instant disclosure for additional direction and guidance.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided support for inhibiting or reducing SARS-CoV-2 infection in a subject in need thereof, as GMI (Ganoderma immunomodulatory protein; instant specification paragraph [0031]) downregulated the expression of ACE2 in lung WI38-2RA cells, a reasonable model for lung tissue (Example 2.5). However, the specification does not provide support for preventing SARS-CoV-2 infection in a subject in need thereof by administering any amount of Ganoderma immunomodulatory protein.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by Fung et al., Ansor et al., and Guo and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to develop a method of preventing SARS-CoV-2 infection in a subject in need thereof, comprising administering an effective amount of Ganoderma immunomodulatory protein comprising SEQ ID NO: 3.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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